本文選題：補(bǔ)腎健脾化痰法　切入點(diǎn)：meta分析　出處：《北京中醫(yī)藥大學(xué)》2016年博士論文　論文類型：學(xué)位論文

【摘要】：目的：評(píng)價(jià)補(bǔ)腎健脾化痰法治療遺忘型輕度認(rèn)知損害(amnestic Mild cognitive impairment,aMCI)的有效性及安全性。方法：本研究正文共分三節(jié)。第一節(jié)對(duì)已發(fā)表的輕度認(rèn)知損害(MCI)中藥臨床藥物試驗(yàn)進(jìn)行系統(tǒng)評(píng)價(jià),計(jì)算機(jī)檢索2000-2015年中國(guó)學(xué)術(shù)期刊網(wǎng)絡(luò)出版總庫(kù),中國(guó)醫(yī)學(xué)數(shù)據(jù)庫(kù),萬(wàn)方數(shù)據(jù)庫(kù),PubMed,Embase中有關(guān)中藥治療MCI的臨床隨機(jī)對(duì)照試驗(yàn),運(yùn)用RevMan5.3.0軟件對(duì)納入研究進(jìn)行數(shù)據(jù)提取并進(jìn)行Meta分析。第二節(jié)采用橫斷面設(shè)計(jì),招募aMCI受試者,進(jìn)行神經(jīng)心理學(xué)測(cè)評(píng)、神經(jīng)影像學(xué)、生化檢查及中醫(yī)證候辨證分型,評(píng)估患者合并的血管因素,觀察aMCI患者合并血管因素是否加重認(rèn)知損害,分析認(rèn)知功能與血管因素、中醫(yī)證候及人口學(xué)特征的相關(guān)性。第三節(jié)為空白對(duì)照研究,治療組選用依據(jù)補(bǔ)腎健脾化痰法制定顆粒劑對(duì)aMCI患者進(jìn)行干預(yù),治療時(shí)間為12周,以認(rèn)知功能及中醫(yī)證候作為療效指標(biāo),同時(shí)評(píng)價(jià)藥物安全性。結(jié)果：1.循證醫(yī)學(xué)研究共納入36項(xiàng)中藥治療MCI的臨床試驗(yàn),meta分析顯示中藥組在改善MCI患者簡(jiǎn)易精神狀態(tài)檢查(MMSE)評(píng)分[MD=1.76,P0.05]及降低癡呆轉(zhuǎn)化率[MD=0.21, P0.05]方面優(yōu)于安慰劑組；中藥組在提高患者M(jìn)MSE [MD=0.90,P0.05]及記憶商(MQ)[MD=6.62,P0.05]和畫鐘測(cè)試(CDT)[MD=0.26,P0.05]評(píng)分方面優(yōu)于基礎(chǔ)治療組；中藥組在改善MMSE[MD=0.78,P0.05]評(píng)分及中醫(yī)癥狀[MD=-6.85,P0.05]方面優(yōu)于西坦類藥物組；中藥在改善MMSE[MD=4.12,P0.05]和中醫(yī)癥狀[MD=-4.14,P0.05]方面優(yōu)于麥角堿類藥物組；中藥組在對(duì)MCI患者M(jìn)MSE[MD=-0.27,0.20),P0.05]、 ADAS-cog[MD=0.38,P0.05]、工具性生活能力(IADL)[MD=-0.58,P0.05]和中醫(yī)癥狀([MD=-1.16,P0.05]的改善方面與鹽酸多奈哌齊組療效無(wú)顯著差異。但36項(xiàng)研究中,35項(xiàng)(97.2%)臨床試驗(yàn)未詳細(xì)記錄用藥安全性,無(wú)法進(jìn)行中藥治療MCI安全性的meta分析。2.橫斷面臨床觀察性研究發(fā)現(xiàn)aMCI伴有血管因素組(aMCI+VF)與不伴血管因素組(aMCI-VF)在中醫(yī)證候陽(yáng)亢上存在統(tǒng)計(jì)學(xué)差異(P=0.024),兩組ADAS-cog與MMSE評(píng)分無(wú)明顯差異(P0.05)。ADAS-cog分項(xiàng)中單詞辨認(rèn)與心率呈正相關(guān)(r=0.304,P=0.002)；指令測(cè)試與BMI呈正相關(guān)(r=0.290,，P=0.003)。3.補(bǔ)腎健脾化痰法治療aMCI的空白對(duì)照研究：試驗(yàn)組78例,空白對(duì)照組15例,治療12周后,試驗(yàn)組阿爾茨海默病評(píng)估量表-認(rèn)知部分(ADAS-cog)評(píng)分變化均值為-0.82,對(duì)照組變化均值為0.33,差異有統(tǒng)計(jì)學(xué)意義(P=0.027)；試驗(yàn)組MMSE評(píng)分變化均值為1.14,對(duì)照組變化均值為-0.67,差異有統(tǒng)計(jì)學(xué)意義(P=0.000)；試驗(yàn)組中醫(yī)證候腎虛、脾虛、痰濁評(píng)分變化均值依次為-1.09,-1.17,-0.89,對(duì)照組中醫(yī)證候腎虛、脾虛、痰濁評(píng)分變化均值依次為1.67,0.63,1.27,差異有統(tǒng)計(jì)學(xué)意義(P=0.001,P=0.026,P=0.000)。治療過(guò)程中不良事件發(fā)生5例,不良反應(yīng)發(fā)生率為6.4%,1例判定與用藥相關(guān)(中藥過(guò)敏),無(wú)嚴(yán)重不良事件。結(jié)論：橫斷面觀察性研究揭示盡管血管因素可能是導(dǎo)致認(rèn)知損害的原因,但血管因素并沒(méi)有影響aMCI患者總體認(rèn)知水平。補(bǔ)腎健脾化痰法可能成為治療aMCI的新途徑,需要開(kāi)展長(zhǎng)療程大樣本的臨床研究進(jìn)一步證實(shí)。
[Abstract]:Objective: To evaluate the effect of Bushen Jianpi Huatan therapy of amnestic mild cognitive impairment (amnestic Mild cognitive impairment, aMCI) efficacy and safety. Methods: This study consists of three sections. The first section of mild cognitive impairment (MCI) has published the systematic evaluation of traditional Chinese medicine clinical trials, 2000-2015 years China academic journal network publishing database retrieval, China medical database, Wanfang database, PubMed, Embase in the randomized clinical trials of traditional Chinese medicine in the treatment of MCI, using RevMan5.3.0 software for data extraction and Meta analysis were included in the study. The second section cross-sectional design, aMCI subjects were recruited, neuropsychological, neuroimaging, biochemical check and TCM syndrome differentiation, vascular factors evaluation in patients with the observation of aMCI in patients with vascular cognitive impairment is aggravating factors, analysis of cognitive function With vascular factors, correlation between TCM syndromes and demographic characteristics. The third section is the control of blank, the treatment group selection method of Bushen Jianpi Huatan granules intervention in aMCI patients, the treatment time was 12 weeks, based on the cognitive function and TCM syndrome as indicators of efficacy, and drug safety evaluation. Results: 1.. Certificate of medical research 36 clinical trials of traditional Chinese medicine in the treatment of MCI were included. Meta analysis showed that the Chinese medicine group in improving the mini mental state examination (MMSE) score in patients with MCI [MD=1.76 P0.05], and reduce the dementia conversion [MD=0.21, P0.05] better than the placebo group; Chinese medicine group in improving patients with MMSE [MD=0.90, P0.05] and memory quotient (MQ) of [MD=6.62. P0.05] and clock drawing test (CDT) [MD=0.26, P0.05] score were better than the treatment group; Chinese medicine group in improving MMSE[MD=0.78, P0.05] scores and TCM symptoms of [MD=-6.85, P0.05] is better than that of zetham Drug group; traditional Chinese medicine in the improvement of MMSE[MD=4.12, P0.05] and [MD=-4.14 P0.05] is better than that of TCM symptoms, ergot drugs group; Chinese medicine group in patients with MCI MMSE[MD=-0.27,0.20), P0.05], ADAS-cog[MD=0.38, P0.05], the ability of life tools (IADL) [MD=-0.58, P0.05] ([MD=-1.16, P0.05] and TCM symptoms improved and the curative effect of donepezil hydrochloride there was no significant difference. But in the 36 study, 35 (97.2%) clinical trials without detailed records of drug safety, can not be meta MCI security analysis of traditional Chinese medicine in the treatment of.2. clinical cross-sectional observational study found that aMCI was associated with vascular factors group (aMCI+VF) and without vascular factors group (aMCI-VF) there were significant differences in the TCM syndrome Yang Kang on (P=0.024), no significant difference between the two groups of ADAS-cog and MMSE score (P0.05) in identifying sub word.ADAS-cog (heart rate had positive correlation with r=0.304, P=0.002 and BMI); test instruction Positive correlation (r=0.290, P=0.003,.3.) control study of Bushen Jianpi Huatan therapy aMCI blank: test group 78 cases, 15 cases of the control group after 12 weeks of treatment, the experimental group of Alzheimer's disease assessment scale cognitive subscale (ADAS-cog) score changes of mean -0.82, mean change in the control group was 0.33, there was statistical significant differences (P=0.027); test group MMSE score changes mean 1.14, control group mean -0.67, the difference was statistically significant (P=0.000); experimental group of TCM syndrome of kidney deficiency, spleen deficiency, phlegm and mean change in score were -1.09, -1.17, -0.89, the control group of TCM syndrome of kidney deficiency, spleen deficiency, phlegm score mean change in the order of 1.67,0.63,1.27, the difference was statistically significant (P=0.001, P=0.026, P=0.000). 5 cases of adverse events during the treatment, the incidence of adverse reaction was 6.4%, 1 cases were judged associated with medications (Chinese medicine allergy), no serious adverse events. Theory: a cross-sectional observational study revealed vascular factors may be the cause of cognitive impairment, but no overall cognitive level and vascular risk factors in patients with aMCI. Effect of Bushen Jianpi Huatan method may be a new way for the treatment of aMCI, clinical research need to carry out the long course of large sample further confirmed.

【學(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：博士
【學(xué)位授予年份】：2016
【分類號(hào)】：R277.7

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